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Mental Health

New ‘miracle’ drug for postpartum depression one step closer to approval

A new “miracle” drug that addresses one of the most common pregnancy complications — postpartum depression — is one step closer to being on the shelves, new research released Wednesday shows. 

Scientists from Northwell Health’s Feinstein Institutes for Medical Research just wrapped up a clinical trial examining the new drug Zuranolone and found more than half of participants saw a full remission of their clinical depression at the end of the trial period. 

The neuroactive steroid pill also worked much quicker than typical antidepressants given to women suffering from the condition — trial participants showed “immediate and sustained results” after just three days of taking the drug, Northwell Health said. 

“Postpartum depression affects one in eight women and currently there is only one FDA approved medication for those women,” Dr. Kristina Deligiannidis, the New York-based principal investigator on the trial, told The Post in a statement. 

Scientists from Northwell Health’s Feinstein Institutes for Medical Research just wrapped up a clinical trial examining Zuranolone. Feinstein Institutes

“Far too long women suffering from PPD feel ashamed or unsure of how to get the help they need. Through further clinical trials, and potential approval of this drug, these women will have help literally at their fingertips.” 

Like other mental health issues that only impact women, postpartum depression — a condition as old as childbirth — has long been understudied and under researched and often goes undiagnosed despite the devastating effects it can have on both mother and child. 

Women suffering from postpartum depression have difficulty bonding with their children or caring for them and are often overcome with feelings of hopelessness, anxiety and crushing beliefs about their perceived ineptitude to be a mother. 

Kristina Deligiannidis, MD, led the Phase 3 clinical trial looking at the safety and efficacy of a potential pill medication for postpartum depression. Feinstein Institute/Northwell He

In serious cases, postpartum depression can lead to suicide and in the most extreme cases, women suffering from the condition have felt impelled to hurt or kill their baby.

Without intervention, PPD can persist for years.  

When Tonya Fulwider was a young mom in 1998, she didn’t realize she had postpartum depression until her daughter was six-months-old. 

Tonya Fulwider in 1998 following the birth of her daughter when she was suffering from postpartum depression. Tonya Fulwider

“Every step felt like walking through concrete,” Fulwider, 47, recalled. 

“People talk about the blues, feeling blue. That is way too bright. Depression is colorless, it’s black, there’s nothing there, there is no hope there and when you have a beautiful new baby, it was just awful.” 

Fulwider, who has since devoted her life to helping women with PPD after starting the non-profit POEM, said she was never asked how she was doing by her pediatrician or her OB-GYN. When she finally told her primary care doctor, he “threw me a script” and sent her on her way. 

“The reality of mom’s mental health being so vital is because she is generally the source of all nurturing, she is generally the one who is providing not only the diaper changes and the feeding but the sing song, the hugs, the warm embrace and babies need that too,” Fulwider said. 

“And if she’s depressed… it’s just torture, it’s fighting, you’re fighting to do everything you have to do and that’s just not fair to mom.” 

The Feinstein Institutes’ Zuranolone trial, part of the drug’s crucial Phase 3 study, examined 151 randomized patients at 33 centers across the US in a double-blinded, placebo-controlled test. 

The Feinstein Institutes for Medical Research at Northwell Health found more than half of participants saw a full remission of their clinical depression at the end of the trial period.  Fein Institutes

By day 15 of taking the drug, 45 percent of women were in remission, versus 23 percent in the placebo group, and by day 45, 53 percent were in full remission, compared with 30 percent who received the placebo. 

Fulwider said she was grateful a new drug could soon be on the market because women who suffer from PPD need all the options they can get. 

“While we can talk all day about mental health is health and that is 100 percent true, it’s much harder, it’s a much more complicated process and it’s even more complicated to get the right kind of care, particularly for moms,” Fulwider explained. 

“We tell moms to white knuckle through this and we’ve got to flip that script.” 

The neuroactive steroid pill also worked much quicker than typical antidepressants given to women suffering from the condition. Fein Institutes